Friday, October 24, 2008

The U.S. Food and Drug Administration today approved an implantable and removable valve system designed to control some air leaks in the lungs that persist after certain kinds of lung surgery.

While air leaks are generally common after lung surgery, prolonged air leaks, which are leaks present seven days after surgery, occur less frequently and make it difficult for patients to breathe. Prolonged leaks also can increase the length of hospital stays and require additional surgeries to close.

The IBV Valve System consists of an implantable valve, a catheter for valve insertion, and a sizing kit, which can be used to measure the target area for valve implantation. The FDA approved this system under the Humanitarian Device Exemption (HDE) program, which supports the development of medical devices intended to benefit patients in the treatment of diagnosis of diseases or conditions affecting fewer than 4,000 people in the United States per year.

This device is approved for use in patients who have undergone partial or total removal of a lung lobe or lung volume reduction surgery and who experience prolonged air leaks or significant air leaks that may become prolonged.

Most air leaks heal themselves. An air leak still present on the seventh day after surgery is considered prolonged, unless it is only noticed during forced exhalation or cough.

An air leak present on the fifth day after surgery is considered a significant air leak that may become prolonged if the leak is always present, present during normal inhalation, or present during normal exhalation and accompanied by emphysema or other respiratory problem.

"This valve may ease post-operative recovery of patients undergoing certain kinds of lung surgery," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "This approval is an example of the agency's commitment to addressing unmet medical needs through the HDE program."

The IBV valve is inserted through a bronchoscope, and placed in the airway of the lung area affected by the air leak. Once inserted, the valve allows air to flow in only one direction, preventing air from entering the affected area but allowing air and mucus to escape.

Potential adverse events include collapsed lung, bleeding, bronchitis and damage to the airway in which the valve is placed. The valve should not remain implanted for longer than six weeks. Patients who cannot tolerate bronchoscopy should not be treated with the device.

The IBV Valve System helped heal air leaks in a small number of patients undergoing lung surgery. A pivotal trial, where the valve system was used to treat emphysema, provided additional safety information as did other studies, such as animal studies, biocompatibility tests, sterilization validation, and packaging and shelf life studies.

The IBV Valve System is manufactured by Spiration, Inc., located in Redmond, Wash. The company will conduct a post-approval study to collect additional safety and benefit information that may be used to enhance labeling for the device.

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